VoirElite 4K 31.5 Surgical Display

GUDID 00860008848925

Surgical Display for Operating Room

Jam-Labs Corp.

Image display unit, colour

• Primary Device ID: 00860008848925
• NIH Device Record Key: 1bb91051-3d86-4265-a500-3cf7e9f9e23f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VoirElite 4K 31.5 Surgical Display
• Version Model Number: JMASM00077/81/82
• Company DUNS: 087271162
• Company Name: Jam-Labs Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008848925 [Primary]

FDA Product Code

• FWC: Camera, Television, Surgical, With Audio

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-23
• Device Publish Date: 2024-01-15

Devices Manufactured by Jam-Labs Corp.

• 00860008848925 - VoirElite 4K 31.5 Surgical Display: 2024-01-23Surgical Display for Operating Room
• 00860008848925 - VoirElite 4K 31.5 Surgical Display: 2024-01-23 Surgical Display for Operating Room
• 00860008848901 - ORION RACK: 2022-09-28 Video Integration Control System
• 00860008848918 - SKYTRON ASCEND IP: 2022-09-28 Video Integration Control System